The Effect of Treatment With Basal Insulin Peglispro or Insulin Glargine on Insulin Sensitivity and the Effect of Prandial Insulin Lispro in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)
研究概览
简要总结
This study will look into insulin sensitivity (how the body responds to insulin) and effects of meals on type 2 diabetics comparing insulin peglispro to insulin glargine. The study has two treatment periods, each of which will last about four weeks. One drug (insulin peglispro or insulin glargine) will be administered in each period. Participants will receive both drugs during the study. Participants may remain on stable dose metformin, as prescribed by their personal physician.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable glycated hemoglobin (HbA1c) less than (<) 10.0 percent (%)
- •Stable dose of either 0.2 to 1.5 units per kilogram per day (U/kg/day) basal insulin or a total daily insulin dose l<2.0 units per kilogram (U/kg)
- •C-peptide <0.3 nanomole per liter (nmol/L)
- •Stable body during the last 2 months
排除标准
- •Corrected QT interval (QTc) prolongation greater than (>) 500 milliseconds (ms) or have any other abnormality in the 12 lead
- •Abnormal blood pressure
- •A history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from Type 1 Diabetes Mellitus (T1DM)), hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data
- •Currently treated with oral antidiabetic drugs (OADs) (excluding metformin and dipeptidyl peptidase-4 (DPP4) inhibitors), or glucagon-like peptide-1 (GLP-1) agonists or intend to use over-the counter or prescription medication, herbal medications, or nutritional supplements that affect PG or insulin sensitivity, impact on hypoglycemic awareness or promote weight loss within 4 weeks prior to randomization
- •Fasting triglycerides (TGs) >400 milligrams per deciliter (mg/dL) (4.52 millimoles per liter (mmol/L))
- •Have used systemic or inhaled corticosteroids/glucocorticoid therapy (excluding topical, intra-articular, and intraocular preparations) within 4 weeks prior to randomization
- •Currently receive insulin by pump or insulin degludec
- •Poorly controlled diabetes or known to have poor awareness of hypoglycemia
- •History of gastroparesis or gastrointestinal malabsorption
- •Require treatment with any drug other than insulin to treat diabetes
- •Previous history of proliferative retinopathy
- •Excessive consumers of xanthines
研究组 & 干预措施
Insulin Peglispro (with Insulin Lispro)
Insulin peglispro, a once daily subcutaneous(SC) injection at bedtime for 5 weeks
干预措施: Insulin Peglispro (Drug)
Insulin Peglispro (with Insulin Lispro)
Insulin peglispro, a once daily subcutaneous(SC) injection at bedtime for 5 weeks
干预措施: Insulin Lispro (Drug)
Insulin Glargine (with Insulin Lispro)
Insulin glargine, a once daily subcutaneous(SC) injection at bedtime for 5 weeks
干预措施: Insulin Glargine (Drug)
Insulin Glargine (with Insulin Lispro)
Insulin glargine, a once daily subcutaneous(SC) injection at bedtime for 5 weeks
干预措施: Insulin Lispro (Drug)
结局指标
主要结局
Pharmacodynamics (PD): Average Glucose Infusion Rate From Euglycemic 2-step Hyperinsulinemic Clamp (M-value)
时间窗: Day 33, last 30 minutes (final step) of euglycemic 2-step hyperinsulinemic clamp
During the euglycemic 2-step hyperinsulinemic clamp, both low and high insulin was infused sequentially during the same procedure. The 2-step clamp procedure allowed insulin sensitivity to be measured in participants and uses a lower dose of insulin of which the effect is largely on the liver and a high dose of insulin at which the effect has reached 100% on liver and effects are largely on glucose uptake in peripheral tissues. Measurements for average glucose infusion rate are collected for both steps (low and high) of the clamp procedure.
次要结局
- Pharmacodynamics (PD): Plasma Glucose Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h), Above Pre Meal Baseline for Insulin Lispro(Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast)
- Pharmacokinetics (PK): Area Under the Concentration Curve Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Prandial Insulin Lispro(Days 30 through 32:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast)
- Pharmacokinetics (PK): Area Under the Concentration Curve Zero Through 5 Hours (AUC 0-5h) for Acetaminophen(Day 29:Pre-dose, 10, 20, 30, 40, 50, 60, 90, 120, 150, 180, 210, 240, 270, 300 minutes post-breakfast)
- Appetite and Satiety Ratings, as Measured Using Visual Analog Scale (VAS) on Day 29(Day 29:Upon waking, pre-breakfast, 1 hour (hr), 2 hr, 3 hr, 4 hr and 5 hr post breakfast)
- Pharmacokinetics (PK): Area Under the Concentration Curve (AUC) for Insulin Lispro During Clamp(Day 33 during euglycemic 2-step hyperinsulinemic clamp)